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U.S. Department of Health and Human Services

Class 2 Device Recall OMNIBotics iBlock Cutting Guide

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  Class 2 Device Recall OMNIBotics iBlock Cutting Guide see related information
Date Initiated by Firm April 12, 2019
Create Date June 04, 2019
Recall Status1 Terminated 3 on May 14, 2020
Recall Number Z-1717-2019
Recall Event ID 82797
510(K)Number K090953  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System.
Code Information MI1218
Recalling Firm/
Manufacturer		 OMNIlife science Inc.
480 Paramount Dr
Raynham MA 02767-1085
For Additional Information Contact Christina Rovaldi
508-822-6030
Manufacturer Reason
for Recall		 The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
FDA Determined
Cause 2		 Under Investigation by firm
Action On April 12, 2019, the firm notified customers of the recall through phone, email, and federal mailing titled URGENT MEDICAL DEVICE ADVISORY NOTICE. Customers were informed that the locking mechanism on the iBlock Cutting Guide may loosen during use. Customers were asked to: -Immediately quarantine lot MI1218 -Return product to the firm -Acknowledge receipt of the notice be completing and returning the Receipt form by fax or email. The firm's investigation is ongoing. For further information contact Christina Rovaldi, Sr. Regulatory Affairs Specialist at 774- 226-1847 or 800-448-6664. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
Quantity in Commerce 9
Distribution US Nationwide distribution in the states of OK, SC, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = PRAXIM MEDIVISION, SA
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